Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

N/ARecruitingNCT04190602

NeoChord500 enrolled

Overview

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Mitral Regurgitation Mitral Valve Disease Mitral Valve Insufficiency Mitral Valve Prolapse Heart Valve Diseases

Interventions

NeoChord Artificial Chordae Delivery System, Model DS1000DEVICE

The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation * Study procedure completed after 31 December 2016 Exclusion Criteria: * Heavily calcified valves * Valvular retraction with severely reduced mobility * Active bacterial endocarditis * Complex mechanism of MR (leaflet perforation, etc.) * Significant tethering of leaflets * Inflammatory valve disease

Locations (5)

University of Bonn

Bonn, Germany

RECRUITING

CVC Frankfurt

Frankfurt, Germany

RECRUITING

University of Mainz

Mainz, Germany

RECRUITING